Status:
TERMINATED
AFP464 in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of AFP464 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of AFP464 in patients with advanced solid tumors. II. Assess the safety and tolerability of this drug in these ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Bilirubin normal
- Platelet count \>= 100,000/mm³
- AST and ALT =\< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance \>= 60 mL/min
- Adequate pulmonary function
- DLCO =\< grade 1
- No symptomatic pulmonary disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to AFP464
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit study compliance
- No smoking within the past 30 days; must be willing and able to completely refrain from smoking during study participation
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or bleomycin) and recovered
- At least 4 weeks since prior radiotherapy; no prior thoracic radiotherapy; no prior radiotherapy to \>= 50% of total marrow volume
- More than 4 weeks since prior experimental therapy (non-FDA-approved agents), immunotherapy, or targeted agents and recovered
- More than 8 weeks since prior UCN-01
- More than 2 weeks since prior hormonal therapy except for patients on androgen suppression for prostate cancer
- Concurrent androgen suppression allowed in patients with prostate cancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- Histologically confirmed malignant solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Tumor amenable to biopsy (maximum tolerated dose expansion cohort)
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- Absolute neutrophil count \>= 1,500/mm³
- No other concurrent anticancer agents or therapies
- Renal cell cancer, breast cancer, and non-small cell lung cancer encouraged
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00369200
Start Date
June 1 2006
Last Update
December 11 2013
Active Locations (1)
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1
Wayne State University
Detroit, Michigan, United States, 48202